Job Description SummaryThe Lead Product Safety Engineer is responsible for ensuring the safety and regulatory compliance of products within the GE HealthCare Ultrasound Probes organization. This role ensures that safety requirements are defined, implemented, and verified throughout all phases of the product lifecycle. The Lead Product Safety Engineer partners closely with design engineering, risk management, quality, regulatory, and manufacturing teams to drive robust safety engineering practices, safeguard patient safety, and ensure compliance with product safety standards.
Job DescriptionRoles and Responsibilities- Serve as a Subject Matter Expert (SME) and local technical authority for product safety of ultrasound probes, following and sharing best practices, and supporting global consistency across programs.
- Partner with the Safety & Risk Engineer and the local Install Base Engineer to apply ISO 14971 throughout the product lifecycle, covering hazard identification, risk analysis, risk control strategies, benefit-risk justification, and final safety sign-off. Maintain and update product Cause & Mitigation Tables (CMT) to ensure all mitigations remain effective and implemented, incorporating post-market feedback and periodic review inputs in a timely manner.
- Lead product-safety-related interactions with Notified Bodies (NB), including owning safety document submissions, preparing technical safety justifications, responding to NB questions or nonconformities, and representing product safety as a SME during NB audits and technical file reviews.
- Own the definition, flowdown, and verification of product safety requirements, ensuring they are appropriately incorporated during concept development, requirements definition, architecture decisions, NPI, design changes, and sustaining activities.
- Act as the local expert for IEC 60601-2-37, IEC 60601-1, IEC 60601-1-2, and related ultrasound safety standards, providing authoritative interpretation and ensuring compliance across design and verification activities.
- Drive resolution of safety-critical issues, including investigation of safety escalations, evaluation of field data, review of design changes, and leadership of cross-functional safety assessments and safety-impact decisions.
- Provide safety engineering leadership for audits, inspections, design reviews, and regulatory submissions, ensuring safety documentation is complete, accurate, and compliant with global regulatory expectations.
- Mentor and develop engineers and support personnel, building safety engineering capability through training, coaching, and technical guidance on standards, safety analyses, and test methodology.
- Monitor and interpret evolving global regulations and safety standards, assessing their impact on product development and work proactively with the Safety & Risk Engineer to integrate new requirements into organizational processes and designs.
Required Qualifications- Bachelor's degree in engineering, physics, or related technical discipline and 5+ years of medical device development experience;
OR 10+ years in medical device engineering/compliance with at least 3 years of hands-on IEC compliance and safety testing experience. - Demonstrated expertise in IEC 60601 series, IEC 60601-2-37, IEC 60529, and other applicable medical electrical equipment standards.
- Strong working knowledge of ISO 14971, including experience leading or contributing to formal device risk management activities.
- Proven ability to lead cross-functional teams, influence technical decisions, and communicate complex safety concepts across diverse technical and cultural environments.
Desired Characteristics- Experience in medical ultrasound, diagnostic imaging systems, or related high-reliability medical devices.
- Familiarity with GE HealthCare's QMS, design control processes, and product development workflows.
- Demonstrated ability to manage multiple priorities, drive complex technical issues to closure, and make sound safety-critical decisions under time constraints.
- Strong analytical, troubleshooting, and problem-solving skills, with the ability to distill complex information into clear technical documentation.
- Excellent written and verbal communication skills, including the ability to author safety justifications, risk-benefit analyses, and regulatory documentation.
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We will not sponsor individuals for employment visas, now or in the future, for this job opening.
Additional InformationGE HealthCare offers a great work environment, professional development, challenging careers, and competitive compensation. GE HealthCare is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
GE HealthCare will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable).
While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19, some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees.
Relocation Assistance Provided: No
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